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Usability for custom made medical devices

#1
Hey,

Iam looking for a usability strategy for solution provider of custom made prosthesis solutions.

Product / Service consists of combination of 3rd party prosthesis parts (having their own CE certifications) which are adjusted to each patient uniquely by the solution provider. So vendor of each part has already provided the evidence of compliance of usability, etc. and solution provider's prosthesis expert make a combination of these parts, adjusts, installs and instructs per each patient.

What would be your strategy for usability validation and usability compliance for the provider of these solutions?

My take: As its an existing product - My plan was to go with UOUP. And for usability evaluation, as each product combination is unique, usability testing with patients is not practical so effort should be on usability of the installation and customization done by the prosthesis expert. For example inspection checklists, etc

Thoughts?
 
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yodon

Staff member
Super Moderator
#2
Do these parts work together in a 'system' or are they all independent? Why do you feel you need a usability evaluation?
 

Tidge

Trusted Information Resource
#3
Writing with the assumption that these are external prosthetic devices that are custom fit for individuals...

If you feel that you need a 'usability assessment' I would think that the most value would come from general analysis of the devices'
  • risks that arise from use when not being employed as a prosthetic (e.g. during cleaning or routine handling)
  • risks that may come from user slips (mental, not physical), lapses, mistakes, and violations of use
Methods involving cleaning and transport could probably be validated no matter the specific customization.

Risks that involve mental model of perception and cognition are more difficult to quantify and assess.

I am not familiar enough with that segment of the medical device industry to know what literature exists, but the history of prosthetics is long enough that some usability risks must be reasonably well understood and have accepted 'industry standard' risk controls for many of them. I doubt that it will be particularly easy to validate any specific customization for a particular patient's customization. The increased odds of survival for battlefield casualties (as well as civilian casualties) over the past decades may have introduced a LOT of literature in this area.
 
#4
Thanks for thorough answers and considerations. Yep, these are external prostethic devices. To yodon - for usability evaluation I mean general methods of validating the mitigations for use error related risks of the product.

Thanks!
 

yodon

Staff member
Super Moderator
#5
for usability evaluation I mean general methods of validating the mitigations for use error related risks of the product.
That's where I'm unclear. You say the components are individually CE marked so they presumably have their own technical file with a UE File. How is it that you are changing the use profile? I can see that if you are providing them to be used as a system that there may be new use cases. Are you maybe providing a separate IFU that describes unique intended uses?

You mention considering the UOUP approach - does that mean you have established a Use Spec, conducted risk analysis, and are gathering and reviewing post-production data? How are the risk controls you defined unique from the original components' controls?

What happens if, as a result of your efforts, you conclude that usability improvements are required?

As you can probably tell, I'm still not convinced you need to do any additional UE work. :)
 
#6
That's where I'm unclear. You say the components are individually CE marked so they presumably have their own technical file with a UE File. How is it that you are changing the use profile? I can see that if you are providing them to be used as a system that there may be new use cases. Are you maybe providing a separate IFU that describes unique intended uses?

You mention considering the UOUP approach - does that mean you have established a Use Spec, conducted risk analysis, and are gathering and reviewing post-production data? How are the risk controls you defined unique from the original components' controls?

What happens if, as a result of your efforts, you conclude that usability improvements are required?

As you can probably tell, I'm still not convinced you need to do any additional UE work. :)
Valid thoughts :).

  • My understanding is that the risk controls are unique (extended) from the original component controls by including the installation of combination of the variety of components and the IFU for the patient for this unique combination of components and patient.
  • If there would be some risks requiring mitigation emerging from use error analysis we would need to check whether they are covered by external components already or part of this "product" / installation.
For the additional UE work, I feel that at least the use definition would need to be in and the risks found via UOUP. Agree that very unlikely additional effort needed - but lets see.
 
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